What are the goals of EPA's Quality System?
The goals of the Agency-wide Quality System are to ensure that environmental
programs and decisions are supported by data of the type and quality needed
and expected for their intended use, and that decisions involving environmental
technology are supported by appropriate quality-assured engineering standards
and practices.

Scientific Data Integrity - EPA will produce data of known
and documented quality based on sound scientific principles.

Reduced or Justifiable Resource Expenditures - Resource expenditures
can be reduced if EPA's information needs are more closely matched to
the information collection. Through proper planning, only the correct
type, amount, and quality of data will be collected for EPA use.

Proper Evaluation of Internal and External Activities - The
EPA Quality System provides documentation of activities and improved
oversight for evaluation purposes. This reduces the potential for waste
and abuse.

Reliable and Defensible Decisions - When the quality of data
is known, it is possible to determine whether the data can be used for
a specific decision. This reduces embarrassing surprises and challenges
to regulations, permit appeals, etc.

Burden Reduction - As EPA better defines the data needed
for a specific application, the burden on other organizations who are
required to collect and/or report data to EPA may be reduced.

Overall, implementation of the EPA Quality System will reduce the Agency's
vulnerabilities and increase EPA ability to make reliable, cost-effective,
and defensible decisions.

What activities does the EPA Quality System
cover? The EPA Quality System covers the collection, evaluation,
and use of environmental data by and for the Agency, and the design, construction,
and operation of environmental technology by the Agency. This includes
environmental programs such as the demonstration of environmental technology;
investigation of chemical, biological, physical, or radioactive constituents;
development, evaluation, and use of computer or mathematical models; use
of data collected for other purposes or from other sources (also termed
"secondary data"); and the collection and use of data pertaining to the
occupational health and safety of personnel in EPA facilities. A list
of some example activities are contained in Example
Activities.

Who is responsible
for the EPA Quality System?
The EPA Quality System is decentralized so each EPA organization designs,
implements, and manages its own quality system. The Assistant Administrator
for Environmental Information is the Senior Quality Management Official
for the Agency as stated in EPA Order
CIO 2105.0 (formerly 5360.1) and
is responsible for the assessment and approval of each EPA organization's
quality system. The Quality Staff, Office of Environmental Information,
supports the Assistant Administrator and is responsible for the development
of Agency-wide policy and procedures and for the oversight of implementation
of the EPA Quality System. The EPA Assistant Administrators, Associate
Administrators, and Regional Administrators have official quality responsibilities
and are responsible for the success of their quality system. Line managers
within each organization are responsible for the quality of data collected
or used by their programs.

What are the roles and responsibilities of the
Quality Staff? The Quality Staff is responsible for coordinating
the implementation of the Agency Quality System, developing Agency policies
and procedures on quality, and providing training on quality issues. The
Quality Staff accomplishes these activities by:

What are the roles and responsibilities of an EPA
Quality Assurance Manager and quality management support personnel?
EPA Quality Assurance Managers are tasked with reporting on quality issues
to their senior management, providing independent oversight, and assuring
the implementation of the organization's quality system. This individual
must function independently of direct environmental data generation, model
development, or technology development responsibility. The Order also
defines the responsibilities of the Quality Assurance Manager and other
quality management personnel to include: facilitating the development
and maintain the organization's Quality Management Plan; representing
the organization on matters pertaining to quality management; providing
expert assistance to project personnel on quality assurance and quality
control issues; developing and implementing a Quality Assurance Training
Program; reviewing and/or approving quality management documentation;
providing quality management support to project personnel; overseeing
and assessing the organization's quality system. In addition to these
general responsibilities, each EPA organization's Quality Management Plan
defines specific responsibilities for its Quality Assurance Manager and
other quality management personnel.

Quality System Documentation - Documentation that describes
the authorities, policies, and procedures specific to an organization's
quality. EPA organizations are required to develop a Quality
Management Plan as documentation.

Annual Reviews and Planning - A yearly review of the activities
within, and changes to, an organization's quality system; work accomplished;
and future projects requiring quality management attention. EPA organizations
are required to submit a Quality Assurance Annual
Report and Work Plan to document this review.

Management Assessments - Assessments of a program and/or organization
to determine the conformance of the quality system to policies, compliance
with regulations, and conformance to the organization's quality system
documentation. EPA uses Quality Systems Assessments
and Audits and other management assessments to assess EPA organizations
and some supporting organizations.

Training - Methods and techniques to ensure that all personnel
having responsibility within the quality system for management and data
collection activities have the skills and knowledge to complete their
tasks in accordance with their quality system's policies and procedures.
EPA organizations are required to document their Training
Program in their Quality Management Plan.

Project Planning - Systematic planning
(for example, the Data Quality Objective Process) is used to develop
performance criteria for the data (i.e., the type, quantity, and quality
of data needed to serve their needs) or technology design, to develop
a plan to satisfy these criteria, and to determine the level of oversight
and quality control activities needed to ensure the criteria are satisfied.
The results from the systematic planning are documented in a Quality
Assurance Project Plan.

Project Implementation - Data are collected and environmental
technology is implemented according to the methods and procedures documented
in the approved Quality Assurance Project Plan, Standard
Operating Procedures, and design documentation. During data collection,
oversight may be performed using technical audits
that are conducted to assess whether or not data are being collected
as stated in the Quality Assurance Project Plan.

Project Assessment - Analysts use technical knowledge and
statistical methods to determine whether or not the collected data meet
the user's needs. The data are formally verified
and validated to ensure that the measured values are free of gross
errors due to procedural or technical problems and then are analyzed
to determine if they meet the performance criteria documented in the
Quality Assurance Project Plan (data quality assessment)
or other design documentation.

How is a 'graded approach' applied to EPA's Quality System? Because
of the diversity of work conducted by the Agency, EPA recognizes that
a "one size fits all" approach to quality specifications will not work.
Therefore, the implementation of the EPA Quality System is based on a
graded approach. Applying a graded approach means that quality systems
for different organizations and programs will vary according to the specific
objectives and needs of the organization. For example, the quality controls
of a fundamental research program are different from that of a regulatory
compliance program because the purpose or intended use of the data is
different. Once a graded approach has been applied to the components of
a quality system, a graded approach is then applied to the documentation
required by that system.